Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China.
Lung Cancer. 2012 Aug;77(2):339-45. doi: 10.1016/j.lungcan.2012.03.012. Epub 2012 Apr 10.
Maintenance therapy, commenced immediately after the completion of first-line chemotherapy, is a promising strategy for improving treatment outcomes in patients with non-small-cell lung cancer (NSCLC). The global phase III SequentiAl Tarceva in UnResectable NSCLC (SATURN) study evaluated the efficacy and safety of the epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor erlotinib as maintenance treatment in NSCLC patients without progression after first-line chemotherapy. We report a retrospective subanalysis of Asian patients enrolled in SATURN. Patients with advanced NSCLC with no evidence of progression after four cycles of chemotherapy were randomized to receive erlotinib 150 mg/day or placebo, until progressive disease or limiting toxicity. The co-primary endpoints of SATURN were progression-free survival (PFS) in all patients and in those with positive EGFR immunohistochemistry (IHC) status. Secondary endpoints included overall survival (OS), disease control rate, safety, quality of life (QoL) and biomarker analyses. In total, 126 patients from East and South-East Asian centers were randomized (14% of the intent-to-treat population): 88 from Korea, 28 from China and 10 from Malaysia; one patient was excluded from this analysis due to Indian ethnicity. PFS was significantly prolonged in the erlotinib treatment arm, both overall (hazard ratio [HR]: 0.57; p=0.0067) and in patients with EGFR IHC-positive disease (HR=0.50; p=0.0057). There was a trend towards an increase in OS, which reached statistical significance in the EGFR IHC-positive subgroup (p=0.0233). The overall response rate was significantly higher with erlotinib compared with placebo (24% versus 5%; p=0.0025). Erlotinib was generally well tolerated and had no negative impact on QoL in this subpopulation. The most common treatment-related adverse events were rash, diarrhea and pruritus. Erlotinib was effective and well tolerated in Asian patients, producing benefits consistent with those observed in the overall SATURN population. Maintenance treatment with erlotinib appears to be a useful option for the management of Asian patients with advanced NSCLC without progression after first-line chemotherapy.
维持治疗，即在一线化疗完成后立即开始，是提高非小细胞肺癌（NSCLC）患者治疗效果的一种很有前景的策略。全球三期Sequential Al Tarceva in UnResectable NSCLC（SATURN）研究评估了表皮生长因子受体（EGFR）酪氨酸激酶抑制剂厄洛替尼作为一线化疗后无进展的 NSCLC 患者维持治疗的疗效和安全性。我们报告了 SATURN 中亚洲患者的回顾性亚分析结果。化疗 4 周期后无疾病进展证据的晚期 NSCLC 患者被随机分为厄洛替尼 150mg/天或安慰剂组，直至疾病进展或出现不可耐受毒性。SATURN 的主要共同终点是所有患者和 EGFR 免疫组织化学（IHC）阳性患者的无进展生存期（PFS）。次要终点包括总生存期（OS）、疾病控制率、安全性、生活质量（QoL）和生物标志物分析。共有来自东亚和东南亚中心的 126 名患者被随机分配（占意向治疗人群的 14%）：88 名来自韩国，28 名来自中国，10 名来自马来西亚；一名患者因印度种族而被排除在本分析之外。厄洛替尼治疗组的 PFS 显著延长，总人群（风险比[HR]：0.57；p=0.0067）和 EGFR IHC 阳性疾病患者（HR=0.50；p=0.0057）均如此。OS 有增加的趋势，在 EGFR IHC 阳性亚组达到统计学显著性（p=0.0233）。厄洛替尼组的总缓解率明显高于安慰剂组（24%比 5%；p=0.0025）。厄洛替尼在该亚组中耐受性良好，对 QoL 无负面影响。最常见的治疗相关不良事件是皮疹、腹泻和瘙痒。厄洛替尼在亚洲患者中有效且耐受性良好，其疗效与 SATURN 总体人群观察到的疗效一致。对于一线化疗后无进展的晚期 NSCLC 亚洲患者，厄洛替尼维持治疗似乎是一种有用的选择。
